IP Update - September 2009
Bilski Meets Biotechnology Claims
Are Humans Animals?
Ninth Circuit Weighs In on Compulsory Nature of
Antitrust Claims and Choice of Law Issues
Teachings Incorporated by Reference for
Anticipation Purposes Need Not Be Individually Named
Concurrences Provide Insight into Federal
Circuit's Views on Stays Pending Re-Examination
Tracking Prosecution History to a Narrow Claim
Construction
Res Judicata Applies Unless Material Differences
Exist In Contested Limitations
Follow the Bouncing Ball ... But Not Outside the
United States
Court Not Lured by Arguments for Attorneys'
Fees
Federal Circuit to Consider Enablement and Written
Description Requirements En Banc
USPTO Releases Post-Bilski Section 101 Examination
Guidelines
On Its Face, Federal Circuit's Decision on
Fraud Provides Substantial Relief to Trademark Registrants
The Third Circuit Defines "Use" in the
Context of Counterfeiting Statute
The Effect of Stipulated Dismissal
Webcasting Music Services Not
"Interactive" When Users Cannot Directly Control the
Songs They Hear
Tenth Circuit Overturns Grant of Summary Judgment
Despite Defendant's "Powerful Arguments" Regarding
Interpretation of Copyright Ownership License
Whether a Process Is a Trade Secret Requires
Consideration of the Process Elements in the Aggregate
Bilski Meets Biotechnology
Claims
By Astrid R. Spain
In a decision that undoubtedly evoked a collective sigh of
relief from the biotechnology community, the U.S. Court of Appeals
for the Federal Circuit reversed a summary judgment of invalidity
and held that methods for calibrating proper drug dosage satisfy
the transformation prong of the Bilski
machine-or-transformation test for patent-eligible subject matter
under 35 U.S.C. section 101. Prometheus Laboratories, Inc. v.
Mayo Collaborative Services, Case No. 08-1403 (Fed. Cir.,
Sept.16, 2009) (Lourie, J.).
Prometheus is the sole and exclusive licensee of two Mayo owned
patents that claim methods for calibrating the proper dosage of
thiopurine drugs, which are used for treating both gastrointestinal
and non-gastrointestinal autoimmune diseases. The drugs are
ultimately broken down by the body into various metabolites; the
patents involve measurements of two of the metabolites,
6-methyl-mercaptopurine (6-MMP) and 6-thioguanine (6-TG). The
patents claim methods that seek to optimize therapeutic efficacy
while minimizing toxic side effects and typically include two
separate steps: "administering" a drug that provides 6-TG
to a subject and "determining" the levels of the
drug's metabolites. The measured metabolite levels are then
compared to pre-determined metabolite levels, "wherein"
the measured metabolite levels "indicate a need" to
increase or decrease the level of drug to be administered so as to
minimize toxicity and maximize efficacy of treatment.
Prometheus marketed a PROMETHEUS Thiopurine Metabolites test
that used the technology covered by the patents in suit. Mayo
initially purchased and used Prometheus's test, but in 2004,
Mayo announced that it intended to begin using and selling its own
test. Prometheus sued Mayo for infringement and ultimately appealed
to the Federal Circuit the district court grant of Mayo's
motion for summary judgment of invalidity under § 101. The
district court found that the "'administering' and
'determining' steps are merely necessary data-gathering
steps for any use of the correlations" and that "as
construed, the final 'wherein' clause is only a mental
step."
On appeal, the Federal Circuit commenced its analysis by noting
that the key issue is whether the claims are drawn to a fundamental
principle (unpatentable) or an application of a fundamental
principle (patentable). The Court noted that it articulated a
"definitive test" for determining whether a process is
patent-eligible under § 101 in Bilski. The
Bilski machine-or-transformation test is a
"two-branched inquiry," under which a patentee may show
that a process claim satisfies § 101 either by showing that
his claim is tied to a particular machine, or by showing that his
claim transforms an article.
Regarding transformation, the Court concluded that the methods
of treatment claimed in the patents-in-suit squarely fall within
the realm of patentable subject matter because they "transform
an article into a different state or thing," and this
transformation is "central to the purpose of the claimed
process." The Court pointed to the transformation of the human
body following administration of a drug and the various chemical
and physical changes of the drug's metabolites that enable
their concentrations to be determined. The Court also noted that
the asserted claims are in effect claims to methods of treatment,
"which are always transformative when a defined group of drugs
is administered to the body to ameliorate the effects of an
undesired condition." The Court further opined that even for
those claims lacking an administration step, patentability is
undiminished because the determining step is also transformative
and central to the claimed methods, as levels of 6-TG or 6-MMP
cannot be determined merely by inspection and without some form of
manipulation. Having concluded that the claimed methods meet the
transformation prong under Bilski, the Court did not
consider whether they also meet the machine prong.
Are Humans Animals?
By Robert H. Underwood
Addressing an interesting issue of patent claim construction,
the U.S. Court of Appeals for the Federal Circuit, sitting as an
expanded five-member panel, held that a human is an animal.
Martek Biosciences Corporation v. Nutrinova, Inc, Case
Nos. 08-1459, -1476 (Fed. Cir., Sept. 3, 2003) (Gajarsa,
J.)(Lourie, J. dissenting-in-part).
Martek owns several patents that cover various aspects of making
and using omega-3 highly unsaturated fatty acids. Nutrinova sells
allegedly infringing products for human consumption. One of the
patents claims a method for increasing the concentration of the
omega-3 acids in an "animal." The district court
concluded that the claim term "animal" does not include
humans. Based on this claim construction, Martek stipulated in the
district court that the claims were not infringed.
The Court, in a three-person majority opinion, concluded that a
human is an animal. The Court reached this conclusion by following
the well-established rule that when a claim term is explicitly
defined in the specification, that definition controls. The patent
specification states that "animal" means any organism
belonging to the kingdom Animalia. According to the Court, the
definition in the specification controls and, because it is
undisputed that humans are members of the kingdom Animalia, the
district court erred in limiting the term "animal" to
exclude humans.
The majority was not persuaded by Nutrinova's assertions
that the disclosure in the specification of a preferred use of the
omega-3 acids to produce food products from economic food animals
and the enumeration of preferred food animals, constitutes a clear
intention to limit the term "animal" to exclude humans.
Again relying on well-established precedent, the Court concluded
that the scope the claimed invention is not so limited, because the
specification does not clearly disclaim coverage of humans. In the
majority's view, this was particularly true because Martek
expressly defined "animal" broadly enough to encompass
humans and also disclosed uses of the claimed invention that are
applicable to humans.
In dissent, Judge Lourie while agreeing with the precedent
relied on by the majority, concluded that this case presents an
"unusual situation" in which the purported definition of
the term "animal" does not comport with the full
description of the invention. In the view of the dissent, based on
the use of the term "animal" in the claims and
specification, one of ordinary skill in the art would conclude that
the term "animal" does not include humans.
Practice Note: While patentees can be their own
lexicographers—and express definitions of claim terms in
the specification are controlling—patent drafters should
take steps to ensure that the broader written description of the
invention and its embodiments comports with any express
definitions. This case was heard by an expanded (five judge) panel
of the Federal Circuit; a rather unusual circumstance. Judges
Newman dna Moore joined in the panel decision and Judge Rader
joined in the dissent.
Ninth Circuit Weighs In on Compulsory
Nature of Antitrust Claims and Choice of Law Issues
By Rachael Lewis and William Diaz
The U.S. Court of Appeals for the Ninth Circuit affirmed the
lower court's dismissal of antitrust claims; finding that in
the claims in issue were compulsory counterclaims that the
defendant had failed to plead in response to a prior patent
infringement lawsuit. The Court held that Destiny Tool failed to
satisfy the pleading requirements for malicious prosecution and
abuse of process under Ohio law. Destiny Tool v. SGS Tools
Company, Case No. 07-17109, 2009 WL 2700319 (9th Cir., Aug.
27, 2009) (per curiam)(non-precedential)
SGS, Dauphin and Destiny manufacture and sell precision-cutting
drill heads. In 2004, SGS and Dauphin filed a patent infringement
suit against Destiny with respect to its "Improved Cutting
Tool." After district court in Cleveland, Ohio, granted
Destiny's motion to dismiss the case with prejudice, Destiny
countered with claims against SGS and Dauphin in the Northern
District of California for malicious prosecution, abuse of process,
monopolization and attempted monopolization. Destiny claimed $2
million in damages in addition to attorneys' fees because of
the initial patent infringement claim. The U.S. District Court for
the Northern District of California dismissed Destiny's suit;
Destiny appealed.
The parties disputed whether Ohio or California law governed the
malicious prosecution and abuse of process claims. While
acknowledging the state of California's interest in protecting
its citizens from unwarranted and...
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